Summary

The anthrax mailings of 2001 increased public and governmental awareness of
the threat of terrorism using biological weapons. The federal response to this
threat includes increases in countermeasure research funding, greater
investment in public health infrastructure, and greater preparation of first
responders who might be the first to encounter such weapons in an event. The
new Department of Homeland Security (DHS) has made preparation against
biological weapon attack a priority and deployed the BioWatch Program to
provide early warning of a mass pathogen release.

The BioWatch Program uses a series of pathogen detectors co-located with
Environmental Protection Agency air quality monitors. These detectors collect
airborne particles onto filters, which are subsequently transported to
laboratories for analysis. It is expected that this system will provide early
warning of a pathogen release, alerting authorities before victims begin to
show symptoms and providing the opportunity to deliver treatments earlier,
decreasing illness and death.

The BioWatch Program, funded and overseen by DHS, has three main elements
each coordinated by different agencies, sampling, analysis, and response. The
Environmental Protection Agency (EPA) maintains the sampling component, the
sensors that collect airborne particles. The Centers for Disease Control and
Prevention (CDC) coordinates analysis, the laboratory testing of the samples,
though testing is actually carried out in state and local public health
laboratories. Local jurisdictions are responsible for the public health
response to positive findings. The Federal Bureau of Investigation (FBI) is
designated as the lead agency for the law enforcement response if a
bioterrorism event is detected. The BioWatch Program has raised concerns in
some quarters, with questions about its general effectiveness, the siting of
pathogen detectors, the reliability of its results, its cost and workforce
requirements, and the ability of public health officials to respond to
BioWatch results. Efforts to develop integrated response plans, lower the
system cost, and develop complementary and next-generation systems continue.

Some aspects of the BioWatch Program may be of particular interest to
policymakers. For example, Congress may be interested in whether these types
of detection systems can substitute for or supplement other mechanisms in
protecting the general populace; whether this detection system was implemented
optimally; how the success of this system is to be evaluated; whether the
implementation, operational, and expansion costs for the BioWatch Program make
it a cost-effective federal investment; and how to optimize and streamline
performance in the future. Since the BioWatch Program is a federal program
implemented using state infrastructure, Congress may wish to examine how this
new program coordinates with already existing public health and
counterterrorism programs, as well as consider the roles and responsibilities
of the federal government and coordination with state governments in an actual
bioterrorism event.

This report will be updated as events warrant.

Introduction

During the 2003 State of the Union address, President Bush announced that
the federal government was "deploying the nation's first early warning network
of sensors to detect biological attack." (1) The
newly formed Department of Homeland Security (DHS), is responsible for
deploying this network, the BioWatch Program, reportedly as part of the
Biological Warning and Incident Characterization System. (2) Funded
and overseen by DHS, the program has three main elements each coordinated by
different agencies, sampling, analysis, and response. The Environmental
Protection Agency (EPA) maintains the sampling component, the sensors that
collect airborne particles. The Centers for Disease Control and Prevention
(CDC) coordinates analysis, the laboratory testing of the samples, though
testing is actually carried out in state and local public health laboratories.
Local jurisdictions are responsible for the public health response to positive
findings. The Federal Bureau of Investigation (FBI) is designated as the lead
agency for the law enforcement response if a bioterrorism event is detected.
The installation of the sensor network is ongoing, with over 30 cities chosen
as locations for these sensors. (3)

The detection of a covert act of bioterrorism, unless detected by the
BioWatch Program, is likely to occur through the diagnosis of ill victims.
Detection is delayed from the time of the actual event by the time required to
develop symptoms and report them. For many pathogens, early treatment,
preferably before symptoms develop, is key to preventing casualties. If early
detection is achieved, it is predicted that therapeutic agents could be
provided in a timely manner to those exposed, reducing the effectiveness of
such an attack and averting the potentially catastrophic nature of mass
pathogen releases. While pathogen detection systems are employed by the
military, such systems were not previously deployed on such a scale in the
civilian sector.

A fundamental question to be asked of the BioWatch Program is whether it is
an appropriate federal response to the threat of bioterrorism. The historic
cases of bioterrorism within the United States have been small in scope, and
likely would not be detected by the current system. Additionally, the Central
Intelligence Agency has reported that while al-Qaeda maintains the goal of
mass casualties, most attacks will be small scale. (4) The
deployment of a bioterrorism detection system with a primary goal of detecting
large releases of pathogen may not be viewed as the optimum response to the
current threat.

The BioWatch Program garners public and Congressional interest for a
variety of reasons, including its cost, the future development and testing of
similar systems, the effectiveness of the currently deployed system, the
process by which this program was chosen and deployed, and the
consequence-management process envisioned in response to a BioWatch warning.
These issues may raise questions about the role that the Department of
Homeland Security plays with respect to the public health infrastructure,
aspects of federal and state communication and coordination, and the role of
the federal and state governments in protecting the populace against
biological attack.

What is the BioWatch Program?

The function of the BioWatch Program is to detect the release of pathogens
into the air, providing warning to the government and public health community
of a potential bioterror event. While there is limited federal government
description of the BioWatch Program, there have been media reports describing
the functional concept. (5)
According to these reports, aerosol samplers mounted on preexisting EPA air
quality monitoring stations collect air, passing it through filters. These
filters are manually collected at regular, reportedly 24-hour, intervals (6) and are
analyzed for potential biological weapon pathogens using polymerase chain
reaction (PCR) techniques. (7) While
filters from the BioWatch program were initially shipped to and tested at a
federal laboratory in California, state and local public health laboratories
now perform the analyses. (8) News
reports suggest that the system tests for the pathogens that cause anthrax,
smallpox, plague, and tularemia (a bacterial illness, sometimes called "rabbit
fever"), but the entire list of pathogens is not publicly available. (9)

The BioWatch equipment is fielded in select cities, reportedly including
Philadelphia, New York City, Washington, DC, San Diego, Boston, Chicago, San
Francisco, St. Louis, Houston, and Los Angeles. (10) The
Department of Homeland Security has not confirmed the exact number of cities
engaged in the BioWatch program, nor the number of pathogens that are detected
using BioWatch equipment. (11) It is
reported that at least 31 cities are included in the BioWatch program, while
according to the minutes of a Centers for Disease Control and Prevention (CDC)
Information Council meeting, the program may expand to as many as 120
cities. (12) While
the exact cost of this program is unknown, the capital costs for installation
in a single city are estimated at $1 million and the yearly budget for
operation at $1 million per city. (13)

The press has reported that the state and local public health labs
conducting BioWatch testing are all part of the national Laboratory Response
Network for Bioterrorism (LRN). (14) The
LRN is a nationwide network composed primarily of local, state, and federal
government laboratories that provide confirmatory testing of potential
bioterrorism pathogens, using consensus protocols. It was developed by Centers
for Disease Control and Prevention (CDC), the Federal Bureau of Investigation,
and the Association of Public Health Laboratories prior to the anthrax
mailings of 2001. It provides confirmatory testing in all 50 state public
health labs, and in additional locations. (15) There
are currently 118 member labs in the LRN.

BioWatch equipment is heavily based on the Biological Aerosol Sentry and
Information System (BASIS), a system developed within the Chemical and
Biological National Security Program of the National Nuclear Security
Administration (now part of the Department of Homeland Security) by scientists
at Lawrence Livermore and Los Alamos National Laboratories. (16) BASIS
is comprised of an air collector coupled to a series of filters. Airborne
particles passing through the system are captured on a filter. The filter
mechanism is designed to roughly determine when an attack occurred by using
sequential filters automatically rotated on an hourly basis. Filters are
removed and tested using PCR for the presence of select pathogens.

BASIS was deployed for both indoor and outdoor monitoring at the Salt Lake
City Olympics in 2002, and was also tested and characterized in urban
settings. (17) Some
conclusions about instrument performance based on these tests were released.
BASIS was characterized as having high specificity, with fewer than 0.005%
false positives per filter measurement, (18) and
high sensitivity. (19)
However, BASIS was noted to be labor intensive, requiring people to collect
filters and perform PCR testing and analysis.

The first incident of a positive BioWatch result was reported on October 9,
2003 in Houston, Texas. The Houston Department of Health and Human Services
reported detecting low levels of the bacterium that causes tularemia.
According to a press release, positive results were detected on three
consecutive days, with negative results on subsequent days. (20) The
response to the positive result was a modest one with precautionary measures
being taken by the local and state public health agencies, including increased
surveillance for human illness; additional environmental sampling and testing;
and assessment of activities in the area that may have caused the sensors to
pick up the organism. There are no indications that this signal was the result
of an intentional pathogen release, but investigation is ongoing with federal,
state and local agency participation. (21) The
Director of the Houston Department of Health and Human Services stated, "We
are investigating to determine if the bacteria was always present or newly
present and if it represents a health threat to the community." These findings
may likely reflect natural "background" levels of the organism in the
environment, and authorities have chosen to enhance surveillance rather than
distributing antibiotics in the affected community. (22)

Reactions to the BioWatch Program

The BioWatch program has received a mixed reaction from experts. While
acknowledging the program may address a noted homeland security vulnerability,
commentators and analysts have raised concerns in a number of areas. This
section presents some of these concerns, including overall strategy, sensor
siting, detector performance, and public health response.

Strategic Issues

Countering the threat of terrorist use of weapons of mass destruction
against civilians has taken on new priority since the anthrax mailings of
2001. President Bush, when announcing the deployment of the BioWatch program
during the 2003 State of the Union Address, stated,

Today, the gravest danger in the war on
terror, the gravest danger facing America and the world, is outlaw regimes
that seek and possess nuclear, chemical, and biological weapons. These
regimes could use such weapons for blackmail, terror, and mass murder. They
could also give or sell those weapons to terrorist allies, who would use
them without the least hesitation.

A goal of the BioWatch program is detection of large releases of biological
weapons, some of which might potentially cause thousands of casualties. (24) Early
notification of a biological attack is presumed to provide a significant
advantage in preventing and treating casualties. Such a "detect to treat" (25)
warning system may limit casualties and fatalities by allowing earlier medical
service to the exposed, avoiding disease progression. A modeling study
concludes that while the earliest possible detection of a hypothetical urban
anthrax release still cannot prevent all deaths, the proportion of lives saved
by detection and intervention within the first day after the event (before
symptoms appear in those exposed) is approximately 40%. (26) With
increasing delay between detection and treatment, greater casualties occur.

Some experts question whether mass biological attack is the most probable
terrorist threat, and suggest that more localized attacks are more likely. (27) It is
suggested by some that the BioWatch monitors would not likely detect indoor or
underground releases, such as within a building or a subway system. (28) There
are historical examples of both indoor releases, the U.S. anthrax mailings in
2001, and outdoor releases, such as the suspected accidental anthrax release
at Sverdlovsk (now Ekaterinburg), Russia in 1979. (29)

Factors influencing the choice of locales to be monitored are another area
of discussion. BioWatch monitors are reportedly deployed in major cities. A
successful mass biological attack on a large city would likely cause high
casualties. The perceived prestige conferred upon a terrorist group following
a successful, large-scale attack may lead terrorist groups to preferentially
target cities. (30) Some
posit that these factors, among others, require special consideration for
major cities. For example, in the debate over homeland security spending, some
have asserted that homeland security funds should be allocated using formulas
that take into account threats, population density, and the presence of
critical infrastructure, rather than on a per capita basis. (31) In
contrast, some have claimed that successful aerosol dissemination near a major
city is less likely due to the higher probability that such an event would be
noticed by officials or citizens. (32)

Some feel that the existence of bioterrorism countermeasures can themselves
serve as a deterrent to the use of these agents. In theory, the BioWatch
program might have this effect, with potential bioterrorists knowing that
cities have early warning capability due to the BioWatch program being
deterred from using biological weapons. Some may conclude that this deterrent
value is enhanced by the general secrecy surrounding BioWatch program details,
such as monitor locations and pathogen lists. The deterrence value may be
difficult to measure, and may alternately direct terrorists toward locations
lacking such detectors. Also, the general secrecy surrounding the BioWatch
program details may lead potential bioterrorists to underestimate the system's
true capability, decreasing the deterrent effect.

Sensor Siting Issues

Technical issues regarding placement of BioWatch monitors are raised as
potential limitations to the system's effectiveness. Some BioWatch monitors
are reportedly co-located with preexisting EPA air quality monitors, (33) though
potentially the monitors could be relocated should the need arise. (34)
Regulations regarding placement of EPA air quality monitors are found at 40
CFR 58, and, among other criteria, placement is designed to assess the impact
of potential pollutant sources for a given area. Since these criteria are
different from those designed for biological detection, the placement of the
EPA air quality monitors may not place the BioWatch monitors in an optimal
configuration for a given area. Some outdoor pathogen releases, particularly
those that might be small, reportedly might avoid detection due to gaps or
limitations in coverage due to siting, even though the monitors themselves
were very sensitive. (35)

The exact locations of the BioWatch monitors are not public knowledge. The
Department of Homeland Security does not confirm the locations of BioWatch
monitors. (36) If the
locations of these monitors were known with great certainty, it might become
possible to avoid them, to degrade their detection capability, or to provide
them false signals or information. The locations of the BioWatch monitors
determine the detection coverage areas and the security of the monitors. Some
law enforcement concerns which may have been employed in developing priorities
for placing and operating BioWatch monitors include: assuring the physical
security of the monitors so that no tampering occurs; guaranteeing that
monitor filters arrive at the testing location in the same condition as when
they were removed from the monitor; and providing that the chain of custody
for potential forensic evidence is established.

A further concern regarding placement of some BioWatch monitors near EPA
air quality sites is that EPA monitors are not equally spaced within a city or
an area. Even if the EPA monitors meet the above criteria with respect to
security, privacy, and access, the irregularity of placement and potential
gaps in coverage between these sites may cause them to be not entirely
appropriate as BioWatch monitors. It is suggested by some that an outdoor
biological warning system would require the placement of monitors as closely
spaced as 300-500 meters. (37)
Neither the official rationale for BioWatch monitor placement nor who
established the placement criteria has been disclosed. It may be that the
reported choice of sites reflects an effort to provide maximal coverage for
the population in a particular metropolitan area. An unnamed spokesman for the
Department of Health and Human Services stated that the goal of BioWatch
siting is to provide coverage for 80% of the population of a particular
area. (38)
Alternately, cost and ease of access are suggested as possible additional
reasons for the reported use of EPA co-locations. (39)

Following a positive signal from a BioWatch monitor, the likely affected
area might be determined through analysis and modeling of potential releases.
Those determined to be inside areas affected by the release might receive
priority treatment. A recent Congressional hearing (40) cast
light on the diversity of programs able to model gaseous releases, but also
highlighted that there is not a single, acknowledged best method for
determining the area of effect of a given release, especially in urban areas
where wind patterns and the effects of turbulence from building geometries is
only partially known. (41) Thus,
determining the exact areas impacted by the release, and hence those
individuals requiring priority treatment, may be more difficult if the
monitors are sub-optimally deployed.

Analytical Issues

As stated above, the BioWatch Program is built from the successes of BASIS,
developed by the Department of Energy. (42) BASIS,
which employs similar technology, was tested by the Department of Energy in a
variety of situations, including laboratory environments and deployment at the
Salt Lake City Winter Olympics in 2002. (43) It is
not fully known what potential changes were made to the BASIS equipment when
it was adapted to serve BioWatch, and how applicable previous testing results
for BASIS are to BioWatch. Some question the ability of the BioWatch test
methods to detect pathogens in a large city environment, especially one with
considerable pollution and airborne particulate matter that might affect
analysis. (44)

Some are concerned that there may be naturally-occurring background levels
of some pathogens in surveyed cities, leading to positive findings in the
BioWatch program which do not result from bioterrorism. (45) While
PCR is a sensitive technique, it reports the presence or absence of a DNA
sequence, providing only a coarse scale of the amount of initial material. The
diseases caused by anthrax, plague, and tularemia bacteria, all on CDC's
Category A list of biological terrorism agents, are not commonly found in
humans, but they are diagnosed as naturally-occurring infections each year in
the U.S. (46)
Certain of these agents are considered endemic, regularly present in the
environment, in certain parts of the country. The BioWatch Program appears to
be premised upon the assumption that all positive detections merit further
investigation, even if there may be a detectable background level of these
pathogens in some areas. In this regard, the BioWatch Program is a simpler
methodological design than surveillance systems that detect deviations from an
anticipated background event level. Such systems have the added burden of
determining thresholds above background which are significant. Those concerned
about detection of naturally occurring background pathogens question how
response plans might take this possibility into account. When airborne
tularemia bacteria was detected by BioWatch sensors in Houston, Texas, other
information, such as the appearance of human illness, was sought to clarify
the BioWatch result.

Further concerns with BioWatch implementation relate to the verification of
positive results and the use of further testing to guide governmental
response. While the number of false positives arising with BASIS was
determined to be very small, (47) it is
unknown whether that rate is directly applicable to BioWatch equipment. The
BioWatch collection filters, under vacuum airflow for several hours, have the
potential to dessicate and kill organisms collected on them, yielding positive
PCR results that cannot be directly confirmed by growth of a pathogen in
culture. (48) PCR
methods are based on the detection of DNA signatures; they do not require that
the organisms be viable, nor do they distinguish whether organisms are viable
or not. For many pathogens of bioterrorism concern, the "gold standard"
confirmatory test is based on growth of the sample in culture. Besides
providing clear confirmation of preliminary results, growing the organism
provides options for further testing. For example, having viable samples of
the pathogen allows for molecular "fingerprinting" and other techniques to
support epidemiologic and law enforcement investigations, as well as allowing
determination of antibiotic resistance. There may be analytical techniques,
other than culture, used to clarify PCR results from BioWatch, and other
activities that could be undertaken to corroborate initial findings, but
whether protocols for these activities are established and communicated to the
state and local authorities that would implement them is not publicly known.

The public health testing model for bioterrorism, in place during the
anthrax attacks of 2001, incorporates confirmatory testing as one of its
operational cornerstones. LRN laboratories use trained personnel to expedite
testing that confirms or refutes preliminary findings. One goal of the LRN is
to minimize the time between an initial signal, such as a "positive" on a
field-screening device that is expected to yield some false positive findings,
and a confirmed result. This process is designed to launch a public health
response swiftly when it is needed, and avoid doing so when it is not. A
large-scale aerosol release of biological agents would necessitate a public
health emergency response of the highest order. While the BioWatch program is
designed to detect a potential aerosol release quickly, if confirmatory
testing is not available, it could lead to triggering response activities
erroneously, potentially consuming limited resources and damaging public
confidence.

A final concern is the threshold for pathogen detection in the BioWatch
system. Since PCR can amplify very small amounts of DNA, such a system could
be very sensitive, theoretically able to detect a single pathogen. On the
other hand, the pathogen deposition onto the filter depends on the rate of air
flow into the monitor. Thus, the pathogen release detection limit is a
combination of at least three factors: the concentration of aerosols passing
over the detector; the duration that the aerosol mist is passing over the
detector; and the amount of air collected through the filters during that
time. (49) Since
these three parameters of equipment performance are not publicly available,
the actual detection limit for BioWatch is not publicly known. As a
consequence, analyst opinion is mixed as to the utility of these monitors,
with some expressing confidence that small releases could be detected, and
others expecting that smaller outdoor releases would fall below the detection
limit. (50) A very
low detection limit is desirable because for some of the potential agents of
bioterrorism, the infective dose in some individuals may also be very low. (51)

The BioWatch program is considered labor intensive. (52)
Collection of filters from the monitors, processing of the filters, and
laboratory analysis all require human intervention. Additionally, the required
laboratory work regularly consumes chemical reagents and disposable equipment,
incurring significant operational cost. Finally, there are additional costs in
administering, overseeing, and managing personnel and mandatory reporting
related to this program. Initial estimates of the costs of the BioWatch
program are reported to be approximately $1 million in initial equipment costs
per city, followed by operational costs of $1 million per city per year. (53) Since
the BioWatch Program was launched in January 2003, it is likely that a more
exact accounting of the recurring costs of this program will become available
in the future.

Public Health Response Issues

If an aerosol release of a biological agent were detected, a two-pronged
response would be initiated, with state and local public health agencies in
charge of an epidemiologic investigation, and the Federal Bureau of
Investigation (FBI) in charge of a law enforcement investigation. (54) The
public health consequence management plan for the BioWatch program is not
publicly available, but based on a generic model for public health activities
following a bioterrorism event, it is likely to include such activities as:
expanded laboratory investigation, identification of affected populations,
guidelines for countermeasure distribution, considerations for management of
mass casualties, and potential restriction of movement of individuals in the
case of a communicable agent. (55) A
likely first step would be aimed at further sampling to quickly confirm and
clarify any positive results from the BioWatch system, including an attempt to
isolate viable organisms, but with an urgency to minimize the time spent
between an initial alert and a decision to launch a public health response.
The public health response to a suspected aerosol pathogen release is likely
to be massive and difficult to implement in a limited manner. It is, in fact,
the intent of the BioWatch program that the public health response be launched
as quickly as possible following a detected release. An often cited
theoretical model of casualties following mass exposure to anthrax concluded
that rapid distribution of antibiotics following detection of the event is a
critical element in reducing fatalities, and could represent a potential
bottleneck in the response. (56)

Another concern is the burden on a public health workforce asked to support
a new program when faced with naturally occurring challenges, such West Nile
virus and Severe Acute Respiratory Syndrome (SARS). At a July 2003 hearing on
biodefense readiness, CDC Director Julie Gerberding noted,

... in the middle of our smallpox program, we
did have to take the very same people and work on a SARS outbreak, and then
a monkey-pox outbreak, and now a West Nile outbreak, and we have a number of
very high priorities throughout CDC and the public health system that
compete for the same personnel. ... we have been in crisis mode for two
years now.

State public health laboratory workers have voiced concern about meeting
their public health duties due to the increase in responsibility for certain
federal programs. (58)
Similar concerns were voiced about impacts on the public health infrastructure
with respect to smallpox vaccination and terrorism preparedness. (59) Since
the day-to-day operation of the BioWatch program was transferred to state and
local public health laboratories, the Department of Homeland Security
attempted to mitigate these impacts by providing for hiring of laboratory
personnel dedicated to supporting the BioWatch program. (60)
Additionally, direct costs of the program, including consumables such as
biological reagents, are provided for by DHS.

Future Directions of the BioWatch Program

Several aspects of the BioWatch Program are undergoing further development.
As stated above, the initial implementation of the system expanded to a
reported 31 cities, (61) with
potentially more areas under surveillance in FY2004. (62) This
expansion may lead to efficiencies, and the alleviation of some current
concerns, as experience is gained and problems are solved.

The Department of Homeland Security, through the Science and Technology
Directorate, is also requesting proposals for next-generation detection
systems for biological countermeasures. The Homeland Security Advanced
Research Projects Agency issued Research Announcement 03-01 which requests
submissions for systems able to continuously monitor urban areas for
biological agents as well as new indoor monitoring systems. (63)

Additional work is being performed at Department of Energy National
Laboratories to complete commercialization of an automated pathogen detection
and analysis capability. This project, called the Autonomous Pathogen
Detection System, would result in a completely automated system. (64) The
developers expect to have the ability to measure up to 100 different agents
and controls per sample, with low false positive and false negative rates and
a relatively low cost per assay. (65)

Research and development efforts on other detection systems continue. For
example, the Department of Defense Chemical and Biological Defense Program
continues to develop and deploy technologies for instantaneous detection of
biological and chemical weapons. (66) Other
prospective technologies include the SensorNet program, which reportedly is
developing a capability to detect chemical, biological, and radiological
dispersion, (67) the
Urban Atmospheric Observatory, (68) which
aims to determine the atmospheric patterns in an urban environment, and DCNet,
a program to map wind currents in the Washington, DC area. (69) Such
research may eventually develop the next generation of biological detection
equipment and could provide valuable raw data for analysis of results arising
from the current BioWatch monitors. A better understanding of urban air flow
may provide for a more exact determination of areas affected by an aerosol
release. (70)

Policy Concerns

Many aspects of the BioWatch Program raise policy questions Congress may
consider in the coming months. One question addressed may be whether this
program is an appropriate federal response to the threat of bioterrorism, both
in scale and scope. If it is deemed to be, Congress may be interested in how
detection systems, such as BioWatch and other prototype systems, are being
used by the Department of Homeland Security to increase national security. The
BioWatch Program was deployed rapidly, with little publicity, but lessons
learned during this process may be applicable to other detection systems that
the federal government develops. Congress may also wish to consider how the
performance of this system is measured and determine whether the funding level
that the BioWatch Program receives is appropriate for its performance or
effectiveness. Future development of more advanced monitoring systems and
further refinement of the BioWatch monitors may also be areas of Congressional
interest. Another issue is how results from the BioWatch monitors are
integrated into state and federal response plans, especially since BioWatch is
a locally operated, federally funded program.

Significant Role of Detection Systems in DHS
Strategy

Distributed detection networks appear to play a significant role in the
Department of Homeland Security's strategy for protecting the United States.
The Department of Homeland Security's Directorate of Science and Technology is
establishing a Biological Warning and Incident Characterization (BWIC) system.
BWIC consists in part of environmental monitoring networks in selected cities
with direct agent detection and a nationwide biosurveillance system looking
for indicators of biological agent exposure in people, animals and plants. The
DHS Under Secretary for Science and Technology McQueary testified that the
BWIC system will be available as a pilot in FY2004. (71) The
DHS also received FY2004 funds for programs to develop and demonstrate
advanced technologies, including sensors, to detect radiation using systems
distributed over a geographic area.

In the further development of such national-level detection systems, what
features might potentially be addressed, and the priorities assigned to them,
is open to debate. One priority setting decision might be the extent to which
the BioWatch system is further deployed. This decision may prompt additional
policy questions. Will further installation of these systems occur only in
metropolitan areas, or will smaller urban, suburban, and/or rural areas also
be eventually included under BioWatch coverage? Should more monitors be
installed in cities currently under BioWatch, so as to increase the likelihood
of detecting a small release? Should monitors be installed inside buildings or
public transportation, where people may be concentrated? Some experts have
criticized the BioWatch program for being primarily designed to detect large
releases while not detecting the potentially more likely small releases. (72) Others
point out that during the Salt Lake City Olympics BASIS was successfully
installed in sporting venues and transport hubs where small releases might be
detected. (73) On the
other hand, deploying multiple sensor units within a particular area may lead
to significant overlap between sensors, providing diminishing returns per
monitor. A complicating factor is the cost of expanding the BioWatch Program
and the increased likelihood of false positives. Since biological terrorism is
often considered to be a low probability/high consequence event, the risk of
an event occurring is balanced against the costs of maintaining the detection
infrastructure necessary to detect the event. Unlike previous investments in
public health preparedness, the BioWatch Program may not have dual-use
application, being predominantly applicable only as an anti-bioterrorism
program. Congress may choose to fund other programs which have greater
dual-use application to gain benefit from such funds if no bioterror event
occurs.

Another area of potential interest to Congress may be the method DHS used
to prioritize development and deployment of national monitoring systems. Other
federal agencies have programs to develop biodetectors and monitoring systems.
These systems use a variety of techniques to detect aerosolized pathogens, but
have often contained undesirably high false positive rates or low sensitivity.
For example, the Department of Defense is developing a "stand-off" detection
system for some uses rather than a point detection system, as is employed by
DHS in the BioWatch Program. (74) In
military settings, the ability to determine whether a threat is posed by an
aerosol cloud at a distance, allows combat troops to don appropriate gear and
equipment. Also, the Department of Defense focuses on detection systems with
real-time detection, (75)
attempting to develop a "detect-to-warn" rather than a "detect-to-treat"
capability. These systems provide higher false positive rates than that
reported for BASIS. Because of the ready availability of protective equipment,
including masks and suits, and the high training provided to troops regarding
this equipment's use, false positives requiring the donning of protective gear
are more acceptable than in a civilian setting. Further research into such
technologies and assessment of the potential performance of these military
detector systems when placed in a civilian environment may be areas for future
study. Congress may also wish to consider how DHS plans to assess the
effectiveness and performance of the BioWatch Program. Since evaluations for
homeland security are still being developed, judging the success of the
BioWatch system may prove challenging in the short term.

Deployment of Other DHS Programs

Another issue is whether the deployment of the BioWatch program, using
federal government technologies, government contractors, and providing little
official information with regards to capabilities and locations, is an
appropriate approach to homeland security vulnerabilities. While the
deployment of BioWatch as a federal program may have increased the speed of
implementation and thus enhanced homeland security, a question remains as to
whether a more effective, efficient, or inexpensive system might be developed
or deployed if greater public and commercial input were involved. Other
homeland security projects, such as radiation detectors, were developed and
commercialized by engaging competitive market forces through requests for
proposals. (76)

Evaluating Effectiveness

Frequently expressed concerns about the BioWatch Program are its lack of
ability to detect smaller outdoor releases, its potential for false positives,
and its capabilities in an urban environment. One way to address these
concerns is by disseminating information about performance characteristics of
the BioWatch Program. This type of information is available for other military
systems, especially chemical detectors. For example, the Department of Defense
released the detection levels for some chemical detection equipment, (77) and
some performance characteristics, such as false positive rates, are provided
for BASIS. (78) Even
if these metrics were not publicly disseminated, providing concrete
information at the state and local level might enhance the BioWatch
effectiveness. Advantages from early detection depend on a timely response to
a biological release. If state and local officials lack confidence in the
monitor performance, consequence management may be delayed, leading to greater
casualties. (79)
Alternatively if officials overestimate the monitor capability, consequence
management activities may be engaged even when there is no need, consuming
valuable resources and generating unnecessary public anxiety. In the case of
the BioWatch detection of airborne tularemia in Houston, the distribution of
countermeasures was not begun, pending the collection of additional
information. One option would be to further refine the decision-making process
invoked upon a positive finding to more optimally achieve the goals of rapid
response to a bioterror event.

Determining the effectiveness of the BioWatch Program in achieving its
public health goal, to minimize casualties by detecting exposures more rapidly
than would otherwise have occurred, will be difficult in any circumstances.
Assessments of public health effectiveness are typically considered in the
context of opportunity cost; are allocations of funds and person-hours
worthwhile, or might they be better used elsewhere? BioWatch, designed to
detect low-probability/high-consequence events, is unlike public health
surveillance programs, which track conditions expected to occur in the
population. CDC publishes an evaluation protocol for surveillance systems, "to
promote the best use of public health resources through the development of
efficient and effective public health surveillance systems." (80)
Information about a number of the performance characteristics typically
described for surveillance systems - including flexibility, data quality, and
representativeness - is not available to the public for the BioWatch Program.
A senior CDC official stated that BioWatch is in the "proof of concept" phase,
a relatively early stage of technology development, and notes that CDC is,
"trying to build systems to assure that once we have true positives, we can
mobilize a response rapidly, but also develop a system for false positives
which we feel could be a potential problem in the future." (81)
Efforts to explain the system to those needing to know, and to coordinate the
activities of multiple agencies at the federal, state and local levels, are
ongoing. (82)

The BioWatch Program draws upon the expertise of three federal agencies,
the Department of Homeland Security, the Department of Health and Human
Services (through the CDC), and the Environmental Protection Agency. Which
agency is best suited to provide oversight and evaluation of the BioWatch
program is an unresolved question. DHS funds and currently oversees the
program, but some may argue that the BioWatch Program is inherently a public
health program. In this case, the Department of Health and Human Services,
potentially through the CDC, would be best equipped to assess the
effectiveness of the program. The CDC has experience in federal/state
relations regarding public health and in the evaluation of public health
surveillance systems. Also, the CDC may be best qualified to judge the
validity of response and consequence management plans following a BioWatch
positive. Advocates for such a view might point to the retention of
bioterrorism-related civilian countermeasure research and development by HHS,
in the Homeland Security Act (P.L.
107-296), as indicative of the expertise retained within that Department.
Others may assert that the BioWatch Program is a homeland security program, in
which case DHS is the logical choice for sole oversight and assessment of this
program. Since the technologies involved during BioWatch development
originated with elements of DHS, that agency may be uniquely qualified to
assess the state of development and deployment of the system.

Because this program cuts across the expertise of different federal
agencies, oversight and evaluation of the BioWatch Program will likely include
the federal agencies involved. The precedent set in the Homeland Security Act
(P.L.
107-296), where a collaborative approach between the Secretary of Health
and Human Services and the Secretary of Homeland Security is required with
respect to civilian human health-related research and development activities
relating to countermeasures for chemical, biological, radiological, and
nuclear and other emerging terrorist threats, (83) may be
a model for assessment of the BioWatch Program. Determining the relative
authorities of the participating agencies may be an area of Congressional
interest.

The Homeland Security Act (P.L.
107-296) also established a Homeland Security Institute. The Act allows
this institute, following a determination by the Secretary of Homeland
Security, to take on the duties of "evaluation of the effectiveness of
measures deployed to enhance the security of institutions, facilities, and
infrastructure that may be terrorist targets," "assistance for Federal
agencies and departments in establishing testbeds to evaluate the
effectiveness of technologies under development and to assess the
appropriateness of such technologies for deployment," and "design of metrics
and use of those metrics to evaluate the effectiveness of homeland security
programs throughout the Federal Government, including all national
laboratories." (84) Some
may advocate that such an institute would provide the necessary mixture of
federal, private, and public opinions to fully evaluate the different
components of the BioWatch Program.

Funding for the BioWatch Program

The degree to which DHS should focus its spending on such a program is an
area of potential Congressional interest. The DHS reportedly spent
approximately $40 million in FY2003 on the BioWatch program. (85) FY2003
funding for the BioWatch Program was reprogrammed from part of the $420
million transferred from the Department of Defense to DHS with the National
Bio-Weapons Defense Analysis Center. (86) The
$40 million for the BioWatch Program represented 12% of the $340 million
dedicated to Biological Countermeasures in FY2003. (87) For
FY2004, the request for the Biological Countermeasures program was $364
million. Congress provided $199 million, in addition to $68 million in
unexpended FY2003 funds, for a total of $267 million, and increased the amount
dedicated to BioWatch. The conference report accompanying Appropriations for
the Department of Homeland Security (P.L.
108-90), in the section on Biological Countermeasures, states "an
additional $15,000,000 is provided for the urban monitoring program." (88)
According to the White House, a total of $38 million, or 14% of the Biological
Countermeasures budget, will be spent on the BioWatch Program. (89)
Whether this focus should continue, the funding levels for the BioWatch
Program, and how high a priority this specific detection system should be for
DHS are areas where Congress may exercise its oversight role.

Future BioWatch Development Priorities

Several of the technological aspects of the BioWatch Program are areas
where gains may be achieved. Areas where successful upgrades of technology
might have significant benefits include reducing the cost of each BioWatch
monitor, both in initial capital outlay and in daily operational cost, further
development of detection methods for more pathogens, or for genetically
modified pathogens, and increasing the automation of the BioWatch
technologies. Improving the current technology might allow coverage of more
people and/or detection of more pathogens for the current cost. Additionally,
research into alternate sensor technologies, such as biological assays, laser
fluorescence, and other more novel techniques, and topics such as more
efficient collection and analysis tools are currently funded by the federal
government. Inclusion of such advances into BioWatch or other detectors may be
worth consideration.

Coordinating Bioterrorism Testing

The BioWatch Program and the Laboratory Response Network (LRN) share common
goals in providing laboratory support for detecting a bioterrorism event, and
both are deployed in state and local public health laboratories, but important
differences may hamper their effective coordination. The BioWatch Program was
developed by the Department of Energy and EPA and was delivered to state and
local public health laboratories in a near-final state in early 2003. (90) It is
managed and funded at the federal level by the Department of Homeland
Security, with state and local public health agencies responsible for
on-the-ground management of laboratory activities and response to positive
findings. The LRN, in contrast, was developed by the CDC, FBI, and state and
local health agencies, with the first set of test methods developed prior to
the anthrax mailings of 2001. The LRN is managed and funded at the federal
level by the Department of Health and Human Services through CDC, and, in a
fashion similar to the BioWatch Program, state and local public health
agencies are responsible for on-the-ground management of network assets and
response to positive findings. (91) The
LRN has the benefit of a longer history as a civilian public health program,
during which time policies, procedures and protocols have matured.

The BioWatch program shares some operational similarities with the LRN, but
there may be areas in which simultaneous operation of the two systems might
prove difficult. Both systems would likely be in significant use during a
bioterrorism event, and handling large influxes of both BioWatch and
environmental samples might cause competition for limited resources. Conflict
might arise in areas including prioritizing samples for testing (triage),
referral testing and data management. (92) On the
other hand, close involvement of BioWatch operation and testing with the
public health community may prove to be of benefit in the case of an actual
attack. In a fact sheet released at the signing of the FY2004 Homeland
Security appropriations bill (P.L.
108-90), the White House noted that the BioWatch program and the LRN are
both early-detection programs for bioterrorism, and that federal partners,
"are working with state and local officials to implement an effective
consequence management plan that incorporates the BioWatch system." (93)

Clarifying Roles and Responsibilities

The BioWatch Program is a federal program, while first responders and some
immediate decision makers are state and local officials. Since the results are
generated from federal equipment operated by federally funded workers in a
state or local public health laboratory, which entity bears ultimate
responsibility for the functioning of the system? What is the chain of
authority for BioWatch results? While it has been reported that states are
developing response plans in the case of BioWatch positives, (94) the
degree of coordination between federal and state officials, and the mechanisms
of federal assistance to states in such an event, appear unclear at this
point. The response plans developed on a state and local level may have
significant differences in approach, depending on the particular resources
available, leading to inconsistent responses to BioWatch positives.
Coordination between adjacent states, and especially coordination with federal
authorities in a potential multi-state event, is crucial to limiting the
public health impact. A variety of considerations, including means to provide
security clearances to essential state and local personnel so they are fully
involved in planning and response activities, remain to be clarified. (95) The
Department of Homeland Security is developing an updated national response
plan which will define the roles the various federal agencies will play in a
national emergency. (96) Areas
of potential Congressional interest include the specificity of federal
guidance to states with respect to results from the BioWatch program, the
coordination and cooperation between federal and state resources following a
BioWatch positive, and the incorporation of BioWatch results into this
national response plan's implementation.

Conclusion

With early detection and treatment of those exposed to biological weapons,
illness and subsequent fatalities may be minimized, and the presence of
BioWatch in urban areas may serve as an effective deterrent to potential
bioterrorists. Some have questioned the effectiveness of such a system. With a
limited number of monitors within a metropolitan area, these critics question
whether potentially more likely smaller-scale events are detected. Others
question whether such a system will provide dependable results upon which
sound decisions are made.

Since much information on BioWatch has not been released to the public, it
is difficult to evaluate criticisms of the system. Many of the technical
issues raised may have been or are being addressed by the Department of
Homeland Security. Agreements on coordination between state and federal
authorities may be developed but not released. Congress, in overseeing the use
of limited homeland security resources, may wish to further assess and oversee
the impacts of BioWatch and its further development.

Footnotes

2. (back)For
a short description of the Biological Warning and Incident Characterization
System, see the statement of Under Secretary Dr. Charles E. McQueary,
Department of Homeland Security, Science and Technology Directorate, before
the House Select Committee on Homeland Security Subcommittee on Cybersecurity,
Science, and Research and Development, at a hearing titled "Homeland Security
Science and Technology: Preparing for the Future," on May 21, 2003.

3. (back)The
White House, Progress Report On The Global War On Terrorism,
September 2003, p. 14.

15. (back)For
background on the LRN, see M. J. R. Gilchrist, "A National Laboratory Network
for Bioterrorism: Evolution from a Prototype Network of Laboratories
Performing Routine Surveillance," Military Medicine, Vol.165,
Supplement 2, 2000, and A.P. Perkins, T. Popovic, and K. Yeskey, "Public
Health in the Time of Bioterrorism," Emerging Infectious Diseases,
Vol. 8, Oct. 2002, available at http://www.cdc.gov/ncidod/EID/vol8no10/02-0444.htm.
See also Department of Health and Human Services, Public Health Emergency
Preparedness: Transforming America's Capacity to Respond, Fact Sheet,
September 11, 2003.

16. (back)Vin
LoPresti, "Guarding the Air We Breathe," Los Alamos Research
Quarterly, Spring, 2003. See also United States General Accounting
Office, Bioterrorism: Information Technology Strategy Could Strengthen
Federal Agencies' Ability To Respond To Public Health Emergencies,
GAO-03-139, May 2003.

17. (back)"Technology
Will Be Used at 2002 Winter Olympics," Newsline, February 8, 2002.

18. (back)A
false positive rate refers to how often a system signals the presence of a
pathogen when no pathogen exists. A false positive rate of less than 0.005%
corresponds to less than one false positive result per 20,000 tests. Vin
LoPresti, op cit.

19. (back)Test
methods are described according to sensitivity, the ability to detect
an agent when it is present, and specificity, the ability to yield a
negative result when the agent is not present. Specificity requires that the
method does not detect closely related organisms, but only the organism(s) of
interest.

24. (back)For
an overview of the impacts of weapons of mass destruction, see Office of
Technology Assessment, U.S. Congress, Proliferation of Weapons of Mass
Destruction; Assessing the Risks, OTA-ISC-559, (Washington, DC, U.S.
Government Printing Office) August 1993.

25. (back)A
"detect to treat" technology provides early notification of a biological
attack, so that effective treatment for those made ill can be provided. This
differs from a "detect to warn" technology which provides warning of an event
before infection occurs. "Detect to treat" and "detect to warn" technologies
differ in timescale, with "detect to warn" technologies having to detect in
real time, a much more difficult task. For a discussion of these issues, see
Jeffery H. Grotte, Frequently Asked Questions Regarding Biological
Detection, Institute for Defense Analysis, Alexandria, Va., November
2001.

26. (back)Lawrence
M. Wein, David L. Craft, and Edward H. Kaplan, "Emergency Response to an
Anthrax Attack," Proceedings of the National Academy of Sciences of the
United States of America, Vol. 100, April 1, 2003, and Lawrence M. Wein,
personal communication, September 8, 2003.

27. (back)For
a representative view, see Amy Smithson and Leslie-Anne Levy, Ataxia: The
Chemical and Biological Terrorism Threat and the US Response, The Henry
L. Stimson Center, Report No. 35, October 2000.

30. (back)For
an overview of factors which may influence a terrorist group to use chemical
or biological weapons, see CRS Report RL31831Terrorist Motivations for Chemical and Biological Weapons Use: Placing the
Threat in Context byAudrey Kurth Cronin.

31. (back)See
Laurence Arnold, "Less Populated States Receive More Money per Capita for
Security," The Associated Press, June 29, 2003.

40. (back)U.S.
House of Representatives, Committee on Government Reform, Subcommittee on
National Security, Emerging Threats and International Relations, Following
Toxic Clouds: Science and Assumptions in Plume Modeling, 108th Congress,
June 2, 2003.

41. (back)For
a representative view, see National Research Council, Tracking and
Predicting the Atmospheric Dispersion of Hazardous Material Releases:
Implications for Homeland Security, (Washington, DC: National Academies
Press) 2003.

42. (back)The
General Accounting Office, for example, states that BASIS was adapted to
process samples from the BioWatch program. United States General Accounting
Office, Bioterrorism: Information Technology Strategy Could Strengthen
Federal Agencies' Ability To Respond To Public Health Emergencies,
GAO-03-139, May 2003. See also Vin LoPresti, op cit.

49. (back)For
an overview of issues related to biological weapon detectors see
Biological Detection System Technologies, Technology and Industrial Base
Study - A Primer on Biological Detection Technologies, North American
Technology and Industrial Base Organization, February 2001.

51. (back)For
example, see T.V. Inglesby, et. al., "Anthrax as a Biological Weapon
2002," Journal of the American Medical Association, Vol. 287, No. 17,
May 1, 2002, noting evidence from primate studies that the infective dose of
anthrax may be as low as one spore, and D.T Dennis, et al.,
"Tularemia as a Biological Weapon," Journal of the American Medical
Association, Vol. 285, No. 21, June 6, 2001, noting evidence that as few
as 10 inhaled Francisella tularensis organisms may cause disease.

53. (back)Laura
Meckler, "Government Deploys Early Warning System For Bioterror Attack,"
The Associated Press, January 22, 2003. It is likely that this
estimate includes salaries for state public health laboratory workers who
perform required sample analysis.

66. (back)For
an overview of the range of equipment being developed and deployed by the
Department of Defense Chemical and Biological Defense Program, see the
Department of Defense Chemical and Biological Defense Program, Volume 1:
Annual Report to Congress, Annex A, 2003.

74. (back)One
example of stand-off detection equipment being developed by the Department of
Defense is the Joint Biological Standoff Detection System (JBSDS). For an
overview of the Department of Defense chemical and biological detection
capability, see Department of Defense Chemical and Biological Defense Program,
Volume 1: Annual Report to Congress, 2003.

75. (back)For
more information about such detection systems, see National Research Council,
Chemical and Biological Terrorism: Research and Development to Improve
Civilian Medical Response, (Washington DC; National Academy Press) 1999.

76. (back)For
example, the Technical Support Working Group holds Broad Agency Announcements
to develop technologies important to members. For more information on the
Technical Support Working Group, see http://www.tswg.gov/.

77. (back)See,
for example, Chemical Casualty Care Division, U.S. Army Medical Research
Institute of Chemical Defense, Medical Management of Chemical Casualties
Handbook, 3rd Edition, July 2000, or National Research Council,
Strategies to Protect the Health of Deployed U.S. Forces; Detecting,
Characterizing, and Documenting Exposures, (Washington, DC: National
Academy Press) 2000.

79. (back)Lawrence
Wein, a mathematician at Stanford University, reportedly stated that for every
day's delay before responding to a 1 kg anthrax release 10,000 additional
people would die. Amanda Onion, "Calculating the Unthinkable,"
ABCNews.com, March 18, 2003.

81. (back)Testimony
of Joseph Henderson, Associate Director for Terrorism Preparedness and
Response , CDC, before the House Select Committee on Homeland Security,
Emergency Prearedness and Response Subcommittee, on September 24, 2003.

90. (back)
Judith Miller, "U.S. Deploying Monitor System For Germ Peril," The New
York Times, January 22, 2003, p. A1.

91. (back)For
an example of a state's use of established LRN assets for its own detection
and response activities, see Leslie Tengelson, et al., "Coordinated
Response to Reports of Possible Anthrax Contamination, Idaho, 2001,"
Emerging Infectious Diseases, Vol. 8, No. 10, October 2002. See also
Julie L. Gerberding, Director, CDC testimony before the House Appropriations
Committee, Subcommittee on Labor, Health and Human Services, and Education,
April 9, 2003, for a recent discussion of CDC's role in maintaining the
Network and its assets.

92. (back)See
James A. Higgins, et al., "A Field Investigation of Bacillus
anthracis Contamination of U.S. Department of Agriculture and Other
Washington, D.C. Buildings During the Anthrax Attack of October 2001,"
Applied and Environmental Microbiology, Vol. 69, No. 1, January 2003.
During the anthrax mailings of 2001, the testing backlog from the limited
resources of the LRN forced laboratory workers from the Department of
Agriculture to extend their testing work beyond USDA-owned buildings.